BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V60 VENTILATOR

    MDR report key: 11536956 · Received March 21, 2021

    Report

    Report Number
    2031642-2021-00978
    Event Type
    Injury
    Date Received
    March 21, 2021
    Report Date
    October 23, 2020
    Product Code
    MNT
    UDI-DI
    00884838089280
    PMA / PMN Number
    K082660
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL COMPLAINT WAS FILED UNDER THE MFR REPORT#: 2031642-2020-04155 BECAUSE OF PHILIPS SYSTEM ISSUE. WE ARE SENDING THE FOLLOWING INFORMATION: FOLLOW-UP#1. (B)(6) 2020. (B)(6) 2021. UDI#: (B)(4). A PHILIPS FIELD SERVICE ENGINEER (FSE) EVALUATED THE DEVICE, THE REPORTED ISSUE WAS NOT DUPLICATED, AND NO FAULT WAS FOUND. NO PARTS WERE REPLACED. THE DEVICE PASSED ALL PERFORMANCE VERIFICATION TESTING. THE DEVICE IS BEING SENT TO BENCH REPAIR FOR ADDITIONAL EVALUATION. THIS REPORTER STATED THAT A PATIENT HIGHLY DEPENDENT ON OXYGEN THERAPY, WITH AN UNKNOWN AGE, GENDER, HEIGHT, AND WEIGHT WAS ADMITTED TO A HOSPITAL ON AN UNKNOWN DATE WITH THE ADMITTING DIAGNOSIS NOT REPORTED. NO RELEVANT MEDICAL HISTORY, RELEVANT PAST DRUG HISTORY OR RELEVANT CONCOMITANT MEDICAL PRODUCTS WERE REPORTED. WHILE ADMITTED ON AN UNKNOWN DATE, THE PATIENT WAS PRESCRIBED CONTINUOUS POSITIVE AIRWAY PRESSURE VENTILATION (CPAP) THERAPY VIA THE RESPIRONICS V60 VENTILATOR WITH SOFTWARE VERSION 3.0, PATIENT CIRCUIT SINGLE-LIMB HEATED WITH PROXIMAL PRESSURE LINE SINGLE-USE (1020523), 22 MM ID (RT139), LOW RESISTANCE BACTERIAL FILTER (312077), FISHER & PAYKEL WATER CHAMBER (MR290), DEP (312149), FISHER & PAYKEL HUMIDIFIER (MR850). THE CPAP PRESCRIPTION AND DEVICE SETTINGS WERE NOT REPORTED. WHILE ADMITTED ON AN UNKNOWN DATE, THE PATIENT WAS RECEIVING CPAP VENTILATION THERAPY VIA THE V60 DEVICE, WHEN THE PATIENT¿S PRESCRIPTION WAS CHANGED TO HIGH FLOW THERAPY VIA THE VIA V60 DEVICE, HOSPITAL STAFF THEN REMOVED THE MASK FROM THE PATIENT, THE V60 WOULD NOT ENTER STANDBY MODE WHILE PREPARING THE DEVICE AND PATIENT INTERFACE FOR HIGH FLOW THERAPY; HIGH FLOW NASAL CANNULA, PRESCRIPTION, AND DEVICE SETTINGS NOT REPORTED, THE PATIENT WAS WITHOUT VENTILATION THERAPY FOR TWO MINUTES, AND EXPERIENCED AN EVENT OF DECREASED PERIPHERAL CAPILLARY OXYGEN DESATURATION (SPO2) TO 88%. NO MEDICAL INTERVENTION WAS REPORTED. THE REPORTED STATED THAT THERE WAS A DELAY IN DELIVERING HIGH FLOW THERAPY. IT WAS REPORTED THAT THE USER FACILITY USES EITHER THE RESPIRONICS AC611 HIGH FLOW NASAL CANNULA OR A FISHER & PAYKEL OPTIFLOW; MODEL NOT REPORTED, AS THE PATIENT INTERFACE. PHILIPS WAS NOT ABLE TO CONFIRM THE REPORTED DEVICE SYMPTOM. PHILIPS WAS UNABLE TO DETERMINE THE CAUSE OF THE REPORTED SYMPTOM AS IT COULD NOT BE REPRODUCED. NO PARTS WERE REPLACED OR RETURNED TO FAILURE INVESTIGATION LABORATORY. THEREFORE, THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. THE RESULTS OF THE BENCH REPAIR EVALUATION WILL BE PROVIDED UPON COMPLETION. FOLLOW-UP (B)(6) 2021. (B)(6) 2021. THE CUSTOMER CANCELLED THEIR REQUEST TO HAVE THE DEVICE EVALUATED AT THE PHILIPS BENCH. THE DEVICE WAS PLACED BACK INTO USE WITH THE CUSTOMER. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE WHEN ATTEMPTING TO CHANGE THE PATIENT FROM HIGH FLOW THERAPY TO CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) THE VENTILATOR WOULD NOT GO INTO STANDBY MODE. IT WAS REPORTED THAT THE PATIENT WAS WITHOUT OXYGEN FOR 2 MINUTES WHICH RESULTED IN DROPPING OF SATURATIONS TO 88%. NO PATIENT HARM HAS BEEN REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433843 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT V60 00884838089280

    Patients

    Seq Age Sex Outcome Treatment
    1